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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Failure to Deliver (2338); Mechanical Jam (2983)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: pending. This solicited case reported by a consumer via a patient support program (psp) concerned a (b)(6) (at the time of initial report) female patient of unknown origin. Medical history was not provided. Concomitant medication included insulin human for diabetes mellitus. The patient received human insulin (rdna origin) regular (humulin r) from cartridge via reusable pen device (humapen ergo ii), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date approximately in 2019. Dosage regimen was not provided. On an unknown date after starting human insulin therapy, she suffered from fatigue so upon visiting her doctor he informed her to stop using it as and she does not need to take insulin anymore. On an unknown date when she stopped using it, she suffered from a diabetic coma and was admitted to the hospital. Her doctor switched her to insulin human (actrapid). On (b)(6) 2021, she started using actrapid in the ergo humapen. On an unknown date in (b)(6) 2021, the humapen got impaired as when she adjusted the dose and pressed to release insulin, the screw did not rotate and since then she was using insulin syringe (pc number: unknown; batch/lot number: 1710d04). On (b)(6) 2021, she was switched back to humulin r again. Outcome for the event of fatigue was recovered and was unknown for the event of diabetic coma. Information regarding the corrective treatment was unknown. Human insulin therapy was ongoing. The patient was the operator of the device and her training status was unknown. The general model device duration of use and the suspect device duration of use was 2 years. The suspect device status was not in use and if the device was returned, evaluation would be performed. The reporting consumer related the event of fatigue with the human insulin therapy whereas did not provide relatedness with the event of diabetic coma. No relatedness was provided between the events and the device. Edit 20 apr 2021: no new information added.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key11724079
MDR Text Key263463202
Report Number1819470-2021-00053
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1710D04
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2021 Patient Sequence Number: 1
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